Gastric contents after fasting in people taking tirzepatide
Ultrasonographic Evaluation of Gastric Content in Fasting Volunteers and in Tirzepatide Users: an Observational and Cross-sectional Study
This project will use bedside ultrasound to see if adults taking tirzepatide, compared with people not on the drug, still have stomach contents after standard fasting.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Israelita Albert Einstein Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07398222 on ClinicalTrials.gov |
What this trial studies
This is an observational, cross-sectional, non-interventional study enrolling 30 adults, 15 currently using tirzepatide and 15 not using the medication. All participants will fast at least 8 hours for solids and 2 hours for clear liquids before a bedside gastric ultrasound to determine the presence of residual gastric content. The primary outcome is the prevalence of a full stomach by ultrasonography in tirzepatide users versus controls, and secondary analyses will examine demographics, duration and dose of tirzepatide, time since last dose, indication for use, and symptoms such as nausea or a sensation of fullness. The study is conducted at Hospital Israelita Albert Einstein in São Paulo using noninvasive, rapid ultrasound measurements without changing participants' treatments.
Who should consider this trial
Good fit: Adults (≥18 years) currently taking tirzepatide who can fast at least 8 hours for solids and 2 hours for clear liquids, and who are not pregnant or postpartum, are ideal candidates.
Not a fit: People with known gastroparesis, those using prokinetic medications, pregnant or postpartum individuals, or anyone for whom gastric ultrasound cannot be performed are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, results could help clinicians identify patients at higher risk of residual gastric contents and guide safer fasting and anesthesia decisions for people using tirzepatide.
How similar studies have performed: Previous studies show GLP-1 receptor agonists slow gastric emptying and bedside gastric ultrasound can detect residual content, but specific data on tirzepatide are limited, so this assessment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older. * Individuals currently using tirzepatide. * Individuals fasting for at least 8 hours for solids and 2 hours for clear liquids without residue. Exclusion Criteria: * Pregnant or postpartum individuals. * Technical limitation for gastric ultrasound assessment. * Presence of risk factors for gastroparesis. * Use of prokinetic medications such as bromopride, metoclopramide or domperidone.
Where this trial is running
São Paulo, São Paulo
- Hospital Israelita Albert Einstein — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Guilherme F Araujo, MD — Hospital Israelita Albert Einstein
- Study coordinator: Guilherme F Araujo, MD
- Email: guifreitasaraujo@gmail.com
- Phone: +5511 2151-3729
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.